{"id":370791,"date":"2024-01-11T00:01:00","date_gmt":"2024-01-10T23:01:00","guid":{"rendered":"https:\/\/medizinonline.com\/une-etude-montre-des-preuves-reelles-defficacite-et-de-securite\/"},"modified":"2024-01-11T00:01:04","modified_gmt":"2024-01-10T23:01:04","slug":"une-etude-montre-des-preuves-reelles-defficacite-et-de-securite","status":"publish","type":"post","link":"https:\/\/medizinonline.com\/fr\/une-etude-montre-des-preuves-reelles-defficacite-et-de-securite\/","title":{"rendered":"Une \u00e9tude montre des preuves r\u00e9elles d&#8217;efficacit\u00e9 et de s\u00e9curit\u00e9"},"content":{"rendered":"\n<p><strong>La pr\u00e9valence de la colite ulc\u00e9reuse (CU) en Suisse est de 1\/500. Depuis 2019, le tofacitinib, un inhibiteur de JAK, est une fl\u00e8che dans le carquois th\u00e9rapeutique. Dans l&#8217;\u00e9tude de phase 3 OCTAVE, il s&#8217;\u00e9tait av\u00e9r\u00e9 efficace pour obtenir et maintenir une r\u00e9mission clinique et endoscopique par rapport au placebo. Cependant, dans le monde r\u00e9el, les donn\u00e9es disponibles en Suisse \u00e9taient jusqu&#8217;\u00e0 pr\u00e9sent insuffisantes. Un groupe d&#8217;\u00e9tude s&#8217;est maintenant pench\u00e9 sur la question.<\/strong><\/p>\n\n<!--more-->\n\n<p>L&#8217;objectif de l&#8217;\u00e9tude post-marketing FACES <em>(First Tofacitinib Experience in Switzerland) <\/em>\u00e9tait d&#8217;\u00e9valuer l&#8217;efficacit\u00e9 et la s\u00e9curit\u00e9 du tofacitinib dans le traitement des adultes atteints de colite ulc\u00e9reuse mod\u00e9r\u00e9e \u00e0 s\u00e9v\u00e8re en Suisse dans des conditions de monde r\u00e9el. Conform\u00e9ment \u00e0 la conception de l&#8217;\u00e9tude OCTAVE, le groupe de recherche a \u00e9valu\u00e9 l&#8217;activit\u00e9 clinique et endoscopique au d\u00e9but de l&#8217;\u00e9tude et aux semaines 8, 26 et 52 \u00e0 l&#8217;aide du score de Mayo, comme l&#8217;a expliqu\u00e9 le professeur Alain Schoepfer, du service de gastroent\u00e9rologie et d&#8217;h\u00e9patologie du CHU de Lausanne et membre du groupe de recherche FACES [1]. Le tofacitinib a \u00e9t\u00e9 administr\u00e9 \u00e0 raison de 2\u00d710 mg par jour pendant la phase d&#8217;induction de 8 semaines et de 2\u00d75 mg pendant la phase de maintien.  <\/p>\n\n<p>Le syst\u00e8me de scoring de Mayo prend en compte la fr\u00e9quence des selles, les saignements rectaux, les r\u00e9sultats de l&#8217;endoscopie et l&#8217;\u00e9valuation globale du m\u00e9decin pour \u00e9valuer l&#8217;activit\u00e9 du CU. Chacune de ces quatre composantes est not\u00e9e individuellement de 0 \u00e0 3, ce qui donne un score total de 0 \u00e0 12.<\/p>\n\n<h3 id=\"baisse-significative-du-score-de-mayo\" class=\"wp-block-heading\">Baisse significative du score de Mayo<\/h3>\n\n<p>Les chercheurs ont inclus 104 adultes dans leur \u00e9tude (\u00e2ge moyen 41 \u00b1 14,4 ans, dur\u00e9e m\u00e9diane de la maladie 6 ans, IQR 3- 11, intervalle 1-44 ans, 48,1% de femmes). Les pathologies des patients \u00e9taient localis\u00e9es :<\/p>\n\n<ul class=\"wp-block-list\">\n<li>Proctite 3,9%,  <\/li>\n\n\n\n<li>colite du c\u00f4t\u00e9 gauche 34,6%,  <\/li>\n\n\n\n<li>colite \u00e9tendue 11,5%,  <\/li>\n\n\n\n<li>Pancolite 50%.  <\/li>\n<\/ul>\n\n<p>Dans le cadre du traitement m\u00e9dicamenteux pr\u00e9alable, tous les participants avaient re\u00e7u de la m\u00e9salazine, du bud\u00e9sonide topique et de la prednisone, et 70,2% avaient \u00e9galement re\u00e7u de l&#8217;azathioprine. Avant le d\u00e9but du traitement par tofacitinib, les patients avaient re\u00e7u en moyenne 2 traitements biologiques infructueux (principalement infliximab et vedolizumab (79% et 62% respectivement), ainsi que golimumab (23%), adalimumab, ustekinumab (20% chacun) et tacrolimus (15%) ; IQR 1-3, intervalle 0-6). 21 sujets (20,2%) ont \u00e9galement re\u00e7u de la prednisone au d\u00e9but du traitement par tofacitinib. Une baisse significative du score de Mayo a \u00e9t\u00e9 observ\u00e9e au fil du temps <strong>(tableau 1). <\/strong> <\/p>\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-full is-resized\"><a href=\"https:\/\/medizinonline.com\/wp-content\/uploads\/2023\/11\/Tab1_GP2_s31.png\"><img fetchpriority=\"high\" decoding=\"async\" width=\"1466\" height=\"635\" src=\"https:\/\/medizinonline.com\/wp-content\/uploads\/2023\/11\/Tab1_GP2_s31.png\" alt=\"\" class=\"wp-image-370651\" style=\"width:500px\" srcset=\"https:\/\/medizinonline.com\/wp-content\/uploads\/2023\/11\/Tab1_GP2_s31.png 1466w, https:\/\/medizinonline.com\/wp-content\/uploads\/2023\/11\/Tab1_GP2_s31-800x347.png 800w, https:\/\/medizinonline.com\/wp-content\/uploads\/2023\/11\/Tab1_GP2_s31-1160x502.png 1160w, https:\/\/medizinonline.com\/wp-content\/uploads\/2023\/11\/Tab1_GP2_s31-120x52.png 120w, https:\/\/medizinonline.com\/wp-content\/uploads\/2023\/11\/Tab1_GP2_s31-90x39.png 90w, https:\/\/medizinonline.com\/wp-content\/uploads\/2023\/11\/Tab1_GP2_s31-320x139.png 320w, https:\/\/medizinonline.com\/wp-content\/uploads\/2023\/11\/Tab1_GP2_s31-560x243.png 560w, https:\/\/medizinonline.com\/wp-content\/uploads\/2023\/11\/Tab1_GP2_s31-240x104.png 240w, https:\/\/medizinonline.com\/wp-content\/uploads\/2023\/11\/Tab1_GP2_s31-180x78.png 180w, https:\/\/medizinonline.com\/wp-content\/uploads\/2023\/11\/Tab1_GP2_s31-640x277.png 640w, https:\/\/medizinonline.com\/wp-content\/uploads\/2023\/11\/Tab1_GP2_s31-1120x485.png 1120w\" sizes=\"(max-width: 1466px) 100vw, 1466px\" \/><\/a><\/figure>\n<\/div>\n<p>A la semaine 8, le taux d&#8217;adh\u00e9sion au tofacitinib \u00e9tait encore de 100%. Apr\u00e8s 26 semaines, 77 des 104 patients (74%) sont rest\u00e9s adh\u00e9rents, et apr\u00e8s un an, ils \u00e9taient encore 63\/104 (60,6%). Aucune thrombose veineuse profonde, embolie pulmonaire, \u00e9v\u00e9nement cardiovasculaire avanc\u00e9 grave ou n\u00e9oplasie n&#8217;a \u00e9t\u00e9 observ\u00e9. Quatre patients ont pr\u00e9sent\u00e9 une r\u00e9activation de l&#8217;herp\u00e8s zoster pendant la phase d&#8217;induction et deux pendant la phase d&#8217;entretien.<\/p>\n\n<p>En ce qui concerne la fr\u00e9quence des selles, tous les patients avaient au moins trois selles de plus que la normale \u00e0 la ligne de base. Apr\u00e8s 52 semaines, cela a pu \u00eatre r\u00e9duit chez presque tous \u00e0 un niveau normal ou \u00e0 1 ou 2 selles de plus au maximum <strong>(Fig. 1).<\/strong><\/p>\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-full is-resized\"><a href=\"https:\/\/medizinonline.com\/wp-content\/uploads\/2023\/11\/abb1_GP2_s31.png\"><img decoding=\"async\" width=\"757\" height=\"1132\" data-src=\"https:\/\/medizinonline.com\/wp-content\/uploads\/2023\/11\/abb1_GP2_s31.png\" alt=\"\" class=\"wp-image-370652 lazyload\" style=\"--smush-placeholder-width: 757px; --smush-placeholder-aspect-ratio: 757\/1132;width:400px\" data-srcset=\"https:\/\/medizinonline.com\/wp-content\/uploads\/2023\/11\/abb1_GP2_s31.png 757w, https:\/\/medizinonline.com\/wp-content\/uploads\/2023\/11\/abb1_GP2_s31-120x179.png 120w, https:\/\/medizinonline.com\/wp-content\/uploads\/2023\/11\/abb1_GP2_s31-90x135.png 90w, https:\/\/medizinonline.com\/wp-content\/uploads\/2023\/11\/abb1_GP2_s31-320x479.png 320w, https:\/\/medizinonline.com\/wp-content\/uploads\/2023\/11\/abb1_GP2_s31-560x837.png 560w, https:\/\/medizinonline.com\/wp-content\/uploads\/2023\/11\/abb1_GP2_s31-240x359.png 240w, https:\/\/medizinonline.com\/wp-content\/uploads\/2023\/11\/abb1_GP2_s31-180x269.png 180w, https:\/\/medizinonline.com\/wp-content\/uploads\/2023\/11\/abb1_GP2_s31-640x957.png 640w\" data-sizes=\"(max-width: 757px) 100vw, 757px\" src=\"data:image\/svg+xml;base64,PHN2ZyB3aWR0aD0iMSIgaGVpZ2h0PSIxIiB4bWxucz0iaHR0cDovL3d3dy53My5vcmcvMjAwMC9zdmciPjwvc3ZnPg==\" \/><\/a><\/figure>\n<\/div>\n<p>Dans cette population suisse de CU, caract\u00e9ris\u00e9e par une \u00e9volution compliqu\u00e9e de la maladie et de multiples \u00e9checs des traitements biologiques, plus de 60% \u00e9taient encore sous tofacitinib \u00e0 la semaine 52, car ils continuaient \u00e0 b\u00e9n\u00e9ficier d&#8217;un b\u00e9n\u00e9fice clinique, conclut le professeur Schoepfer. Avec un profil de s\u00e9curit\u00e9 favorable, aucun patient n&#8217;a \u00e9t\u00e9 trait\u00e9 simultan\u00e9ment par des st\u00e9ro\u00efdes syst\u00e9miques aux semaines 26 et 52.<\/p>\n\n<p><em>Congr\u00e8s : Congr\u00e8s annuel de la SSH 2023<\/em><\/p>\n\n<p><\/p>\n\n<p>Source :<\/p>\n\n<ol class=\"wp-block-list\">\n<li>Schoepfer A : Expos\u00e9 &#8220;Real-life efficacy and safety of tofacitinib to treat moderate-to-severe ulcerative colitis in Switzerland&#8221; ; Congr\u00e8s annuel de la Soci\u00e9t\u00e9 Suisse de Gastroent\u00e9rologie (SSG), Interlaken, 14.09.2023.<\/li>\n<\/ol>\n\n<p><\/p>\n\n<p class=\"has-small-font-size\"><em>PRATIQUE DE LA GASTROENT\u00c9ROLOGIE 2023 : 1(2) : 31 (publi\u00e9 le 27.11.23, ahead of print)<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>La pr\u00e9valence de la colite ulc\u00e9reuse (CU) en Suisse est de 1\/500. Depuis 2019, le tofacitinib, un inhibiteur de JAK, est une fl\u00e8che dans le carquois th\u00e9rapeutique. Dans l&#8217;\u00e9tude de&hellip;<\/p>\n","protected":false},"author":7,"featured_media":301335,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"pmpro_default_level":"","cat_1_feature_home_top":false,"cat_2_editor_pick":false,"csco_eyebrow_text":"Tofacitinib dans la colite ulc\u00e9reuse","footnotes":""},"category":[11527,11414,11315,11535,11549],"tags":[15761,47187,17477,69203,72866,72865,21282],"powerkit_post_featured":[],"class_list":["post-370791","post","type-post","status-publish","format-standard","has-post-thumbnail","category-etudes","category-gastro-enterologie-et-hepatologie","category-medecine-interne-generale","category-rapports-de-congres","category-rx-fr","tag-colite-ulcereuse","tag-cu-fr","tag-inhibiteurs-jak","tag-mayo-score-fr","tag-remission-clinique","tag-remission-endoscopique","tag-tofacitinib-fr","pmpro-has-access"],"acf":[],"publishpress_future_action":{"enabled":false,"date":"2026-05-18 01:54:45","action":"change-status","newStatus":"draft","terms":[],"taxonomy":"category","extraData":[]},"publishpress_future_workflow_manual_trigger":{"enabledWorkflows":[]},"wpml_current_locale":"fr_FR","wpml_translations":{"it_IT":{"locale":"it_IT","id":370807,"slug":"lo-studio-mostra-prove-di-efficacia-e-sicurezza-nel-mondo-reale","post_title":"Lo studio mostra prove di efficacia e sicurezza nel mondo reale","href":"https:\/\/medizinonline.com\/it\/lo-studio-mostra-prove-di-efficacia-e-sicurezza-nel-mondo-reale\/"},"pt_PT":{"locale":"pt_PT","id":370818,"slug":"estudo-mostra-evidencias-reais-de-eficacia-e-seguranca","post_title":"Estudo mostra evid\u00eancias reais de efic\u00e1cia e seguran\u00e7a","href":"https:\/\/medizinonline.com\/pt-pt\/estudo-mostra-evidencias-reais-de-eficacia-e-seguranca\/"},"es_ES":{"locale":"es_ES","id":370741,"slug":"el-estudio-muestra-pruebas-reales-de-eficacia-y-seguridad","post_title":"El estudio muestra pruebas reales de eficacia y seguridad","href":"https:\/\/medizinonline.com\/es\/el-estudio-muestra-pruebas-reales-de-eficacia-y-seguridad\/"}},"_links":{"self":[{"href":"https:\/\/medizinonline.com\/fr\/wp-json\/wp\/v2\/posts\/370791","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/medizinonline.com\/fr\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/medizinonline.com\/fr\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/medizinonline.com\/fr\/wp-json\/wp\/v2\/users\/7"}],"replies":[{"embeddable":true,"href":"https:\/\/medizinonline.com\/fr\/wp-json\/wp\/v2\/comments?post=370791"}],"version-history":[{"count":2,"href":"https:\/\/medizinonline.com\/fr\/wp-json\/wp\/v2\/posts\/370791\/revisions"}],"predecessor-version":[{"id":373627,"href":"https:\/\/medizinonline.com\/fr\/wp-json\/wp\/v2\/posts\/370791\/revisions\/373627"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/medizinonline.com\/fr\/wp-json\/wp\/v2\/media\/301335"}],"wp:attachment":[{"href":"https:\/\/medizinonline.com\/fr\/wp-json\/wp\/v2\/media?parent=370791"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/medizinonline.com\/fr\/wp-json\/wp\/v2\/category?post=370791"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/medizinonline.com\/fr\/wp-json\/wp\/v2\/tags?post=370791"},{"taxonomy":"powerkit_post_featured","embeddable":true,"href":"https:\/\/medizinonline.com\/fr\/wp-json\/wp\/v2\/powerkit_post_featured?post=370791"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}